Short facts  
API Ketorolac
Technology Sublingual
Indication Acute moderate to severe pain
Development phase Phase 1
Expected filing with FDA 2021 or 2022
In-house or partnership In-house

Unmet medical need

For many opioid dependent patients, their dependence starts with the first exposure to opioids to treat short-term pain, e.g., after an accident or minor procedure. It is estimated that about 8–12 percent1 of people who have been prescribed opioids for longer use will develop an addiction, and today approximately 4 to 5 million Americans are dependent opioid users. In the wake of the opioid crisis, there is a tremendous need to find non-opioid alternatives to effectively treat acute pain and to avoid exposure to opioids.

The concept

OX338 is based on a new sublingual tablet formulation of ketorolac for acute treatment of moderate to severe pain. Ketorolac is a potent NSAID with analgesic effect comparable to many opioids used for short term pain management and can thus replace opioids for many procedures and indications reducing overall opioid consumption.

1 Vowles et al. Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis, Pain (April 2015)